Mental Health Research in Eating Disorders

NIH GUIDE, Volume 25, Number 23, July 12, 1996

PA-96-064

Keywords:
Emotional/Mental Health
0715091
Etiology
Epidemiology
Neuroscience

National Institute of Mental Health
National Institute of Dental Research
National Institute of Diabetes and Digestive and Kidney Diseases
Office of Research on Women’s Health

PURPOSE

The National Institute of Mental Health, (NIMH), National Institute of Dental Research (NIDR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and Office of Research on Women’s Health (ORWH) invite applications for studies relevant to the neuroscience, epidemiology, etiology, treatment, services research, and prevention of eating disorders (anorexia nervosa, bulimia nervosa, and binge eating disorder), and their comorbidity with other medical, dental/craniofacial, and psychiatric disorders. The purpose of this program announcement is to promote additional mental health research emphasis on the broad array of influences, including gender, on eating disorders and ingestive behaviors.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, "Mental Health Research in Eating Disorders" is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the superintendent of documents, government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800).

ELIGIBILITY REQUIREMENTS

A variety of funding mechanisms are encouraged within this announcement, and eligibility and requirements for these funding mechanisms vary. Applicants are advised to contact NIMH, NIDR, or NIDDK program staff listed under INQUIRIES for additional information and specific application procedures.

Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for Small Grants (R03), Education projects (R25), or First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators.

MECHANISM OF SUPPORT

Applications are requested under the following mechanisms: research project grant (R01), small grant (R03), and FIRST award (R29). Applications to NIMH are also requested under the education projects (R25) mechanism. For additional information concerning Mental Health Education Projects, see the NIH Guide, Vol. 25, No. 14 May 3, 1996). For research in method development, the small grant (R03) is a particularly appropriate mechanism; investigators may also choose to include method development as one component within research project grant (R01) applications.

Support may be requested for a period of up to five years, except for small grants (R03), which are limited to two years. FIRST awards must be requested for five years. Annual noncompeting awards will be made subject to continued availability of funds and progress achieved. Because Education Projects, and FIRST awards have special eligibility requirements, dollar ceilings, application formats, and review criteria, applicants are strongly encouraged to consult with program staff (listed under INQUIRIES below) and to obtain the appropriate additional announcements for those grant mechanisms.

An applicant planning to submit a new (type 1) investigator-initiated grant application requesting $500,000 or more in direct costs for any year is advised that he or she must contact Institute program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the applicant must obtain agreement fro the staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in the cover letter that is sent with the application, the staff member and Institute who agreed to accept assignment of the application. Any application subject to this policy that does not contain the required information in the cover letter sent with the addition information concerning large grant applications, see the NIH GUIDE, Vol. 25, No. 14 (May 3. 1996).

RESEARCH OBJECTIVES

Summary

Mental health disorders encompassing eating disorders and ingestive behaviors are an area of increasing public concern in the United States. Anorexia nervosa is a syndrome characterized by body weight severely below normal, body-image disturbance, and an intense fear of and resistance to weight gain. Bulimia nervosa is a syndrome characterized by repeated episodes of binge-eating followed by a variety of purging or other compensatory behaviors such as vomiting, laxative or diuretic use, excessive exercise, and/or fasting. Body weight, however, may remain in the normal range. Binge eating disorder is a recently identified syndrome in which there are repeated episodes of binge eating without subsequent regular purging behavior, typically resulting in body weight above normal limits.

It is estimated that anorexia affects from .5 to 1 percent of teenage and young women, and bulimia from one to three percent. women are 8 to 10 times more likely to suffer from anorexia or bulimia than en. Estimates of binge eating disorder range from about one to four percent of the population with women being about 1.5 times more likely to have this disorder than men. It has been estimated, on average, that 30 percent of enrollees in weight reduction programs suffer from binge eating disorder.

Eating disorders, which may become chronic, frequently have serious psychological and medical consequences. Virtually all bodily systems are affected by starvation, and cardiac, gastrointestinal, and electrolyte disturbances are most common. Clinical depression and anxiety disorders commonly co-occur with eating disorders. Morbidity and mortality in anorexia nervosa are among the highest of any mental disorder. It has been estimated that some 10 percent of patients with anorexia nervosa will die from complications of the disorder.

Eating disorders have a high degree of comorbidity with other psychiatric disorders, as well as with some medical disorders. In anorexia nervosa, affective disorders are most common, followed by anxiety disorders with obsessive compulsive disorder most prevalent. Among patients suffering from bulimia nervosa, high rates of affective disorder and anxiety disorders have been reported, as well as personality disorders and substance abuse. Binge eating disorder is associated with a higher degree of psychiatric comorbidity than is found in obese people who do not binge eat. Also, a "failure to thrive" syndrome, characterized by malnutrition, depression, and physical illness had been described in geriatric populations. Despite their high degree of comorbidity, eating disorders are distinct disorders; they do not transmute into other illnesses.

Research Scope and Goals

New research on the psychosocial and biological factors underlying eating disorders is needed to clarify issues of etiology and treatment. While a broad array of epidemiological, familial, biological, and treatment studies have identified promising leads, major questions in these areas remain unanswered.

This program announcement emphasizes the need for research on eating disorders at all levels from fundamental studies of brain and behavior which identify basic mechanisms, to examinations of risk factors, to epidemiological and clinical investigations which help to successfully diagnose and treat the disorders. The overall goal is to establish a clearer understanding of the etiology, and treatment of these complex disorders, and ultimately, to prevent them.

Eating Disorders research applications are welcome in the following broad areas:

1. Neuroscience and Behavioral Science

The regulation of energy and nutrient balance involves multiple complex systems in the brain and body. Integrative and interdisciplinary approaches will help us understand the genetic, immune, endocrine, neural, and behavioral determinants of energy balance, storage and body weight. Neural circuitry and neurophysiological research in animal models of ingestion have now advances to where the important role of genetic and other molecular factors are rapidly being discovered. There is a pressing need to apply this knowledge to non-human primates and humans, and for the basic research approaches to be integrated with the development of new drugs in the clinical setting. Research in the following areas is encouraged:

2. Epidemiology and Comorbidty

3. Behavioral Medicine

Little is known about the prevention of eating disorders and studies are needed that increase understanding of the behavioral aspects of eating disorders. Such studies include the:

4. Treatment Studies

Treatment studies have suggested the efficacy of specific pharmacological and psychosocial interventions for some patients with eating disorders. While there is general agreement that a multidimensional treatment approach, including individual, group and/or family psychotherapy, psychopharmacotherapy, and behavioral interventions is necessary to treat most patients with eating disorders, few controlled clinical trials have been undertaken to evaluate these treatment modalities. Integrated treatment studies are particularly important to determine the efficacy of combined psychosocial and pharmacologic therapies and the active components of each of these treatments.

Because of the serious physical health and mental health consequences of anorexia nervosa, bulimia nervosa, and binge-eating disorder, treatments for these disorders and intervention strategies to prevent their recurrence need to be developed and tested. Such treatments need to be studied across various stages of the life cycle and of the disorder. With the growing database of efficacious short-term treatments for some eating disordered patients, emphasis should be placed on longer-term trials aimed at maintaining or building upon the improvement obtained during acute treatment. Treatment studies should acknowledge the chronic nature of most eating disorders and assess outcome accordingly, including, but not limited to, a studied interventions success and safety in maintaining healthy eating and activity habits, preventing relapse, and ameliorating other comorbid mental or physical health disorders. Controlled treatment studies are needed to:

5. Services Research (NIMH only)

Previous research suggests that while efficacious treatments exist for some forms of eating disorders, little is known about their effectiveness--how they work in real world settings. Furthermore, little is known about improving the identification of affected individuals, including the development of valid screening tool and effective programs targeting high risk populations; access and pathways to treatment; and the cost-effectiveness of various forms of treatment. The following are examples of research issues that are covered under this announcement:

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as subjects in Clinical Research," which have been published in the Federal Register for Grants and Contracts, Volume 23, Number 11, March 18,1994.

Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 1040, Bethesda, MD, 20892, telephone: (301) 435-0715. The title and number of the program announcement must be typed in Section 2 on the face page of the original application.

Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST award (R29) applications submitted without the required number reference letters will be considered incomplete and will be returned without review.

The completed original application and five legible copies must be sent or delivered to :

Division of Research Grants
National Institutes of Health
6701 Rockledge Drive, Room 1040 MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second level review by the appropriate national advisory council or board.

Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board.

Review Criteria

The initial review group will also examine the provisions for the protection of human and anima subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research.

AWARD CRITERIA

Applications will compete for available funds with all other approved applications. The quality of proposed projects (as determined by peer review), the availability of funds, and program priority will all be considered in making funding decisions.

INQUIRIES

Inquiries are encouraged. Institute staff welcome the opportunity to clarify any issues or questions from potential applicants.

Please direct inquiries regarding programmatic issues to:

Harold Goldstein, Ph.D
Clinical Director, Eating Disorders Program
National Institute of Mental Health
Parklawn Building, Room 10-85
Rockville, MD 20857
Telephone: (301) 443-4140
FAX: (301) 443-4045
Email: hg11p@nih.gov
Dr. Patricia S. Bryant
Behavior, Pain, Oral Function, and Epidemiology Program
National Institute of Dental Research
Building 45, Room 4AN-24K
Bethesda, MD 20892
Telephone: (301) 594-2095
FAX: (301) 480-8318
Email: BryantP@DE45.nidr.nih.gov
Susan Z. Yanovski, M.D.
Division of Digestive Disease and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Building 45, Room 6AN-18
Bethesda, MD 20892-6600
Telephone: (301) 594-8882
FAX: (301) 480-8300
Email: yanovskis@ep.niddk.nih.gov
Direct inquiries regarding fiscal matters to:
Diana S. Trunnell.
Grants Management Branch
National Institute of Mental Health
Parklawn Building, Room 7C-08
Rockville, MD 20857
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email: Diana_Trunnell@nih.gov
Sharon Bourque
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Building 45, Room 6AS-49M
Bethesda, MD 20892-6600
Telephone: (301) 594-8846
Email: bourques@ep.niddk.nih.gov
Martin Rubinstein
Division of Extramural Activities
National Institute of Dental Research
Natcher Building 45, Room 4AN-44A
Bethesda, MD 20892-6402
Telephone: (301) 594-4800
FAX: (301) 480-8301
Email: Martin.Rubinstein@nih.gov
The National Institute of Nursing Research (NINR) is not a co-sponsor of this program announcement, but it is interested in related research on eating disorders. For information concerning related research interests, contact:
J. Taylor Harden, Ph.D., RN
Division of Extramural Activities
National Institute of Nursing Research
Natcher Building 45, Room 3AN-12, MSC 6300
Bethesda, MD 20892-6300
Telephone: (301) 594-5976
FAX: (301) 480-8260
Email: THarden@ep.ninr.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos. 93.242 (NIMH), 93.121 (NIDR) and 93.848 (NIDDK). Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994).

The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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